In this edition of The Precedent, we outline the decision in Regeneron Pharms., Inc. v. Mylan Pharms. Inc. In Regeneron Pharms., Inc. v. Mylan Pharms. Inc., the Federal Circuit affirmed the district court’s grant of a...more
Under U.S. law, most patents are limited to a term of 20 years from the earliest nonprovisional filing date. However, Patent Term Adjustment (PTA) and Patent Term Extension (PTE) can be used in certain circumstances to gain...more
Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more
Cabometyx® (cabozantinib (L)-malate) - Case Name: Exelixis, Inc. v. MSN Labs. Private Ltd., No. 22-228-RGA, 2024 WL 4491176 (D. Del. Oct. 15, 2024) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Cabometyx®...more
On January 29, 2025, the CAFC issued opinions affirming the preliminary injunctions issued against biosimilars of Regeneron’s EYLEA® (aflibercept): Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (CAFC Case Nos. 24-1965,...more
The basis for obviousness-type double patenting (ODP) is found in 35 U.S.C. § 101, establishing an applicant is entitled to a single patent, “a patent” or the “first” patent, for an invention....more
The Supreme Court denies Cellect LLC's petition for certiorari to consider whether patent term adjustment ("PTA") should be included in patent term for obviousness-type double patenting ("ODP") purposes....more
Since serving as a Federal Circuit clerk, Michael Hawes has monitored that court's precedential opinions and prepares a deeply outlined index by subject matter (invalidity, infringement, claim construction, etc.) of relevant...more
In Wisconsin Alumni Research Foundation v. Apple, the Federal Circuit expanded the preclusive effect of non-infringement rulings. It ruled that prior judgments of non-infringement can prevent follow-on lawsuits involving...more
In a new precedential decision issued August 13, 2024, the Court of Appeals for the Federal Circuit in Allergan USA. v. MSN Labs, 24-1061, held that a first-filed, first-issued parent patent that receives a patent term...more
Co-authored by Sam Cohen, Summer Associate 2024. On May 29, 2024, the Western District of Oklahoma in SIPCO, LLC v. JASCO Prods. Co. dismissed the plaintiff SIPCO’s patent infringement claims against defendant JASCO because...more
In In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), the US Court of Appeals for the Federal Circuit held that a later-expiring patent can be invalid for obviousness-type double patenting (ODP) in view of an earlier-expiring,...more
A recent case in the Western District of Oklahoma shines a spotlight on the patent danger posed by errors in a terminal disclaimer. In this case, a typographical error in the filed terminal disclaimer rendered an ensuing...more
In August 2023, the Federal Circuit in In re Cellect held that in evaluating unpatentability for obviousness-type double patenting (ODP) of a patent that has received patent term adjustment (PTA), the relevant date is the...more
The Federal Circuit denied Cellect, LLC's petition for rehearing en banc of the In re Cellect case, which held that the expiration of a patent for obviousness-type double patenting ("ODP") purposes is the expiration date...more
The District Court for the District of Delaware recently held on summary judgment that a patent with 2,295 days of combined patent term adjustment (PTA) and patent term extension (PTE) was not invalid for obviousness-type...more
As part of the recovery from the global COVID-19 pandemic, the U.S. Court of Appeals for the Federal Circuit took steps to return to normal operations. It began requiring live oral arguments in August 2022 and, by November,...more
ACI’s Advanced Summit on Life Sciences Patents is back in person on June 2–3 in New York City. Our reimagined 2022 conference will provide practical insights on how to implement bullet-proof patent prosecution tactics,...more
Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more
The Federal Circuit held recently that the "all substantive rights" test, used heretofore to determine the identity of the "patentee" for purposes of satisfying 35 U.S.C. § 281, should be the standard for determining common...more
In two recent decisions, the US Court of Appeals for the Federal Circuit found that an asserted patent was not invalid due to obviousness-type double patenting (1) when a patent filed post-Uruguay Round Agreements Act of 1994...more